| Pharmacovigilance, the surveillance of the safety of a medicinal product over its life on the market, is very important in the first five years of a new drug, since side effects are unknown. |
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| There is no "one-size-fits-all"
solution since the internal source of safety
data, the reporting requirements, and the
analytical techniques required vary from
company to company. With our extensive experience
in this area, we have developed a unique
solution framework for a customizable application
for Safety Signal Detection, based on best
practices that can significantly decrease
the go-to-market time. For this we use our
existing regulatory validation framework
to enable compliance of the proposed system
with 21CFR Part11 and other regulatory requirements.
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| Additionally, our solutions for Adverse Event Reporting can: |
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- Analyze data to identify early signals
- Proactively identify safety issues
- Better synchronize with FDA's Adverse Event Reporting Systems
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| We have delivered several benefits that can help in achieving basic infrastructure objectives such as: |
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- Implement sophisticated algorithms
that define parameters to identify safety
alerts
- Analyze safety data using graphical
tools
- Conform to CIOMS and MedDRA standards
- Integrate with third-party sources,
such as IMS, AERS, and FDA
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| With extensive domain, technology, and business process expertise in the Healthcare and Life Sciences industry, Cognizant is the preferred partner for several pharmaceutical companies. |
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